SerhiiP
☆    

Ukraine,
2022-01-20 10:20
(377 d 09:19 ago)

Posting: # 22734
Views: 1,051
 

 With food administration [Design Issues]

Dear Members,

I have a question here.

If SmPC only states that the medicine should be taken with food, does this means we should administer medicine with food(and wich timings that is?), or do we administer immideately after food?
Just couldn't find any answer about that :confused:.

Thanks!
dshah
★★  

India/United Kingdom,
2022-01-20 12:49
(377 d 06:50 ago)

@ SerhiiP
Posting: # 22735
Views: 969
 

 With food administration

Dear SerhiiP!
As per the EMA guideline-"In case the study is to be performed during fed conditions, the timing of administration of the drug product in relation to food intake is recommended to be according to the SmPC of the originator product. If no specific recommendation is given in the originator SmPC, it is recommended that subjects should start the meal 30 minutes prior to administration of the drug product and eat this meal within 30 minutes."
Please find the guideline here.
Regards,
Dshah
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